(60 days)
Not Found
No
The device description focuses on the mechanical components (plates, screws, instruments) and materials, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies are mechanical bench tests, not studies evaluating algorithmic performance.
Yes.
The device is indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia, talus, and calcaneus, which is a therapeutic intervention aimed at treating medical conditions.
No
The device is an Ankle Fusion Plating System intended for surgical fixation of ankle arthrodesis and fractures, not for diagnosing medical conditions.
No
The device description explicitly states it is composed of a plate and screws made of Ti6Al4V, and includes a dedicated instrument set and targeting device. These are all physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Description: The provided text describes a surgical implant (plate and screws) used for fixing bones in the ankle. It is a physical device implanted into the body during surgery.
- Intended Use: The intended use is for "anterior fixation of ankle arthrodesis and fractures," which is a surgical procedure.
- No Mention of Specimens: There is no mention of analyzing any specimens from the body.
- No Diagnostic Purpose: The device's purpose is mechanical fixation, not providing diagnostic information based on biological samples.
Therefore, based on the provided information, the In2Bones Ankle Fusion plating system is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The In2Bones Ankle Fusion plating system is indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia, talus and calcaneus. The addition of a compression screw through the tibiotalar joint (example IBS™ 6.5mm screw) is required.
Product codes (comma separated list FDA assigned to the subject device)
HRS, HWC
Device Description
The Ankle Fusion Plating System is composed of an anatomically contoured plate, with a distal part adapted to the talar neck, and a proximal part adapted to the distal tibial epiphysis and diaphysis. Rigid fixation is achieved by screws.
The Ankle Fusion Plating System implants (plate and screws) are manufactured from Ti6Al4V. A dedicated instrument set is available for the bone preparation, screw sizing and insertion of the Ankle Arthrodesis Plating System. A specific targeting device is available for the insertion of the additional I.B.S® 6.5mm screw.
Sizes:
The Ankle Fusion Plate is available in one size, with left and right versions.
Fixation screws are available in 3.5 or 4.5mm diameter, with length ranging from 10 to 100mm.
Material: The Ankle Fusion Plating System implants (plate and screws) are manufactured from Ti6Al4V, as per ISO 5832-1 and ASTM F136.
Single use: The Ankle Fusion Plating System is designed for single use only.
Sterilization: The Ankle Fusion Plating System is supplied sterile, using gamma irradiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ankle, distal tibia, talus, calcaneus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
use in a hospital, or outpatient surgery center where sterile field may be created and maintained.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing of the Ankle Fusion Plating System was assessed through mechanical bench testing performed by an independent test laboratory, animal and clinical testing being considered not applicable. Testing performed included static and dynamic compression tests on Ankle Fusion Plating System. The results indicate that the Ankle Fusion Plating System met the acceptance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K073375, K083032, K141735, K133691, K022255, K121425
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 28, 2017
In2Bones SAS % Ms. Christine Scifert Executive Vice President MRC-X, LLC 6075 Poplar Ave, Suite 500 Memphis, Tennessee 38119
Re: K173121
Trade/Device Name: Ankle Fusion Plating System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: September 27, 2017 Received: September 29, 2017
Dear Ms. Scifert:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173121
Device Name Ankle Fusion Plating System
Indications for Use (Describe)
The In2Bones Ankle Fusion plating system is indicated for anterior fixation of ankle arthrodesis and fractures, including the distal tibia, talus and calcaneus.
The addition of a compression screw through the tibiotalar joint (example IBS™ 6.5mm screw) is required.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for IN2BONES. The logo is set on a gray oval shape. The text "IN2BONES" is in white, with the "2" in orange. A white curved line runs from the top left to the center of the oval.
K173121 Page 1 of 3
| Sponsor
identification | In2Bones SAS
28 chemin du Petit Bois
69130 Ecully – France
Phone: +33.4.72.29.26.26
Fax: +33.4.72.29.26.29 |
|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
registration number | 3010470577 |
| Date of preparation | November 8, 2017 |
| Contact person | Christine Scifert, MS, MEM
MRC-X, LLC
6075 Poplar Avenue, suite 500
Memphis, TN 38119
Cell: 901-831-8053
Email: Christine.Scifert@mrc-x.com |
| Proprietary Name | Ankle Fusion Plating System |
| Common name | Ankle Fusion Plating System |
| Device
classification
regulation | 21 CFR 888.3030: Single/multiple component metallic bone
fixation appliances and accessories
Class II |
| Device Product
Code and Panel | HRS: plate, fixation, bone
HWC: screw, fixation, bone
87 orthopedics |
| Device Description | The Ankle Fusion Plating System is composed of an
anatomically contoured plate, with a distal part adapted to the
talar neck, and a proximal part adapted to the distal tibial
epiphysis and diaphysis. Rigid fixation is achieved by screws. |
| | The Ankle Fusion Plating System implants (plate and screws) are
manufactured from Ti6Al4V. A dedicated instrument set is
available for the bone preparation, screw sizing and insertion of
the Ankle Arthrodesis Plating System. A specific targeting
device is available for the insertion of the additional I.B.S®
6.5mm screw. |
| | Sizes:
The Ankle Fusion Plate is available in one size, with left and
right versions.
Fixation screws are available in 3.5 or 4.5mm diameter, with
length ranging from 10 to 100mm. |
| | Material: The Ankle Fusion Plating System implants (plate and
screws) are manufactured from Ti6Al4V, as per ISO 5832-1 and
ASTM F136. |
| | Single use: The Ankle Fusion Plating System is designed for
single use only. |
| | Sterilization: The Ankle Fusion Plating System is supplied
sterile, using gamma irradiation. |
| | Place of use: The Ankle Fusion Plating System is indicated for
use in a hospital, or outpatient surgery center where sterile field
may be created and maintained. |
| Predicate Devices | Primary Predicate:
Tibiaxys (K073375), Newdeal, Acquired by Integra
LifeSciences |
| | Additional Predicates:
Peri-Loc Ankle Fusion Plating System (K083032), Smith and
Nephew
Ankle Fusion Plating System (K141735), Arthrex
ExtremiLock Ankle Fusion Plating System (K133691),
Osteomed
LCP Ankle Arthrodesis Plate (K022255), Synthes
Ortholoc3Di Ankle Fusion Plating system (K121425), WMT |
| Indications for use: | The In2Bones Ankle Fusion plating system is indicated for
anterior fixation of ankle arthrodesis and fractures, including the
distal tibia, talus and calcaneus.
The addition of a compression screw through the tibiotalar joint
(example IBSTM 6.5mm screw) is required. |
| Comparison of the
indications for use
with the predicate
devices: | The indications for use for the In2Bones Ankle Fusion Plating
System are similar to the predicate devices Newdeal Tibiaxys
(K073375), Smith and Nephew Peri-Loc Ankle Fusion Plating
System (K083032), Arthrex Ankle Fusion Plating System
(K141735), Osteomed ExtremiLock Ankle Fusion Plating
System (K133691), Synthes LCP Ankle Arthrodesis Plate
(K022255), and Wright Medical Ortholoc3Di Ankle Fusion
Plating system (K121425) |
| Comparison of
Technological
characteristics and
Substantial
Equivalence
Summary: | The In2Bones Ankle Fusion Plating System is similar to the
predicate devices Newdeal Tibiaxys (K073375), Smith and
Nephew Peri-Loc Ankle Fusion Plating System (K083032),
Arthrex Ankle Fusion Plating System (K141735), Osteomed
ExtremiLock Ankle Fusion Plating System (K133691), Synthes
LCP Ankle Arthrodesis Plate (K022255), and Wright Medical
Ortholoc3Di Ankle Fusion Plating system (K121425) in
intended use, design, size ranges, principle of operation and
materials. |
| Summary
Performance Data | Performance testing of the Ankle Fusion Plating System was
assessed through mechanical bench testing performed by an
independent test laboratory, animal and clinical testing being
considered not applicable.
Testing performed included static and dynamic compression
tests on Ankle Fusion Plating System. The results indicate that
the Ankle Fusion Plating System met the acceptance criteria. |
| Pyrogen testing | The method used to make the determination that the device meets
pyrogen limit specification is the Limulus Amebocyte Lysate
(LAL) test in accordance with ANSI/AAMI ST72:2011:
Bacterial endotoxins - Test methods, routine monitoring and
alternative to batch testing. |
| CONCLUSION | Based on the comparison of indications for use and
technological characteristics and the results of the testing
performed, the Ankle Fusion Plating System is substantially
equivalent to the predicate devices identified in the 510(k)
submission. |
4
5